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You will probably have experienced this. You are the sponsor of a small project. It is not really a heavy project but t

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

he activities are not part of the daily routine. Also there is some risk involved, basically it is a project without a

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

eal plan. There is however a final date set.

And then, the activities start. You have done your part of the project in

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

the beginning which was the basis for others to complete the work. In fact this could be anything where some expertise

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

s required on which you depend on others.

You ask how things are going, and as always, in the beginning “everything is

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

going fine.” But how do you know this? In the case where there would be a project and a real plan, you would focus on a

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

tivities and dates which are due some moment in time. But now these are not really defined. There is no real control.

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

he end of the story is that when the deadline is near, the work is not finished. And then what? Do you make a plan afte

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

all? You ask what is going on... You would like to know where the problem is?

Project management rule # one; if there

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

is no project there is no control and you depend on the circumstances. A normal reaction of an organization is to "inst

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

ll" a (formal) project management approach. There are many cultural differences amongst companies and countries in this

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

area of project management. They differ in the approach they choose. But equally important in whatever approach is the

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

communication around the project.

Ideally you would like to add as little overhead to you project, up to the point tha

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

you are still able to manage it. The benefit of a formal project planning is that risks are controlled, but the questi

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

n is – at what price? For smaller projects you should focus on the risk areas. But you do not know them. So you should

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

sk. Project management is much to do about communication. About exchanging information and building up knowledge.

If

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

ou are a sponsor, ask for the risks that are involved. You do not want and have to know the details, but you want some

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

roof (of the concept). Make sure you have those risks outlined over time. This give both parties some moments in time

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

o focus on. And you may be relieved knowing that when the risks are controlled the project is safe.

Project management

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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If your business is at the stage where it needs to raise capital from investors or lenders, you must have all of your books and records in good order. Start early before you want to raise capital and get your books and records in good order to make the process go more smoothly. Your investors or lenders will want to see organized and complete records that they will review while doing their due diligence.

What do you do when your staff wants part time work but you have full time needs and seasonal needs. Sometimes the wisdom of your staff can help you plan the best situation. Read this short story about a rural CPA firm and how they grew a business with a variety of staffing opportunities.

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